ISO 80601-2-12 applies to the basic safety and essential performance of a critical care ventilator, combined with its accessories, hereafter referred to as ME equipment.
These ventilators are:
— Intended for use in a critical care environment, where specialized care is provided for patients with life-threatening conditions, requiring comprehensive care and constant monitoring in a professional healthcare facility.
— Considered life-sustaining devices for this document.
— Can provide ventilation during transport within a professional healthcare facility, making them transit-operable ventilators.
— Not considered emergency medical services environment ventilators when intended for transport within a professional healthcare facility.
Additionally, these critical care ventilators are:
— Intended to be operated by a healthcare professional operator.
— Designed for patients who require varying levels of support from artificial ventilation, including ventilator-dependent patients.
ISO 80601-2-12 is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
The text of ISO 80601-2-12:2023 has been approved in Europe as EN ISO 80601-2-12:2023 without any changes.
